Configurable Manifold of Flexboy® Bioprocessing Bags

Configurable Manifold of Flexboy® Bioprocessing Bags
Configurable Manifold of Flexboy® Bioprocessing Bags
from 50 mL to 50 L
Product Information
Manifold of Flexboy® Bioprocessing Bags are designed for
processing and especially for distribution of fluids from one
process step to several identical bags volumes via the main
line. The Flexboy® Bags are then disconnected for further
processing, storage and trans­portation of biopharmaceutical
solutions, intermediates and final bulk products. They provide a
single-use alternative to traditional glass, stainless steel vessels
and rigid plastic carboys in a large variety of applications.
Description
Configurable Manifold of Flexboy® Bags (CTO: Configure to Order)
are designed from a database of pre-qualified components and
proven functionalities, using a web-based and interactive Product
Configurator tool. The user friendly Product Configurator tool
provides the flexibility needed for the application-based singleuse configuration whilst improving design and quotation turn
around times, manufacturing lead times, security of supply,
product reliability, safety and robustness.
Applications
The Manifold of Flexboy® Bags is especially designed for fluid
distribution from one process step to several identical volumes of
bags with filtration, sampling and further connections capabilities.
The broad chemical compatibility of Flexboy® Bags assures the
safe processing of a wide range of biopharmaceutical fluids in a
variety of applications such as:
– Buffers and media sterile filtration, distribution, pooling and
storage
– Bulk harvest and distribution or pooling
– Fraction collection
– Sample collection
– Bulk intermediate filtration, distribution or pooling and hold
– Final product distribution, pooling and storage.
Fluid Management Systems
Flexibility
Configurable Manifold of Flexboy® Bags are configured from
pre-qualified components and proven functionalities including
a variety of tubing, connectors, filter and sampling methods for a
streamlined incorporation into your process. Multiple configurations are available with thermoweldadable TPE tubing, compatible
with Biowelder® and Biosealer® for aseptic connection | disconnections, silicone TuFlux® tubing compatible with Clipster® Aseptic
Disconnector and qualified for peristaltic pumping. An extensive
range of filters (Sartopore® 2, Sartopore® Platinum, Sartopore® 2
XLG, XLM and Sartoguard NF) are proposed with an optional flush
bag. Needle free sampling port or sampling bags may be used for
easy and convenient sampling. Quick couplers, tri-clamps, Steam
Thru valves and Sterile-to-Sterile connectors as Opta® are provided
for optimal connection flexibility in a production environment.
Easy Implementation
Configurable Manifold of Flexboy® Bags, gamma sterilized are
available in bag chamber volumes between 50 mL and 50 L.
They are supplied sterilized and ready to use. This allows an easy
and convenient process implementation. A series of associated
systems such as Flexboy® Trays and Racks facilitate an easy bag
handling. Sartorius Stedim Biotech supports users already at
the design & implementation phase of a new production facility
with the most comprehensive support program that ensures
successful design implementation of single-use Manufacturing.
Features
Pre-qualified component
database and proven
functionalities
Standard components
& manufacturing Methods
Instant design with a webbased Product Configurator
CTO dedicated supply chain
and manufacturing planning
Offer a large range of
standardized configurable
products
Product Configurator tool
with pre­­­configured options
& functionalities
Most commonly used
components and
solutions in the market
Benefits
Quality by design for improved
product reliability
Save on development and
engineering costs
Shorten lead time for drawing &
quotes
Shorten lead-time for products
Reduce complexity and risks by
Standardization
Flexibility for optimal design
tailored to the application needs
Compatibility with end user
process requirements
Security of Supply
Sartorius Stedim Biotech expertise in designing single-use
manifolded solutions combined with collaborative supplier
management, multiple manufacturing sites and customer demand
planning assure a state of the art product supported by a robust
supply chain that can cope with strong market growth.
Validation
Flexboy® Bags have been qualified applying the most comprehensive test regimes. Biological, chemical and physical tests combined
with extensive extractables testing provide users of Configurable
Flexboy® Bags with data representing the widest range of process
fluids in a variety of processing conditions. Full compliance with
ISO 11137 allows for a validated claim of sterility on all Sartorius
Stedim Biotech single-use products with a sterility assurance level
of 10-6 over the shelf life.
Quality Assurance
Sartorius Stedim Biotech Quality Systems for single-use products
follow applicable ISO and FDA regulations. Design, Manufacture
and Sterilization processes are conducted under conditions that
mirror biopharmaceutical operations and meet cGMP requirements.
Flexboy® Bags are tested for compliance to:
– USP<85>: Bacterial endotoxins
– USP<87>: Biological reactivity tests, in Vitro
– USP<88>: Biological reactivity tests, in Vivo
– USP<661>: Tests for plastic
– USP<788> and E.P. 2.9.19: Particulate
– ISO 11737: Bioburden
– ISO 11137: Sterilization of Medical Devices
Supply Chain
Configurable Manifold of Flexboy® Bags are available as Configured
to Order Products (CTO). Pre-configured products based on
application knowledge allow savings on engineering time and
production preparation, thus providing reduced lead times
compared to classical fully customized processes.
Configurable Manifold of Flexboy® Bags
Bag Chamber
Multiple layer film, including EVOH gas barrier layer & EVAM® contact layer
Volumes
50 mL – 50 L
Number of bags in the Manifold 2 to 10 bags up to 20 L
2 to 5 bags for 50 L
Number of ports on bags
3 ports
Tubing
Silicone Tuflux® or Silicone (Pt)
TPE compatible with BioWelder® & BioSealer®
End Connectors
Quick Couplers
Tri-clamp & Mini Tri-clamp
Luer Locks
Steam thru valves for SIP connections
Sterile-to-Sterile connectors including Opta® sterile connector
Filters
Sartopore® 2 0.2µm Gamma MidiCaps® & MaxiCaps® T-Style
Sartopore® Platinum 0.2µm Gamma MidiCaps® & MaxiCaps® T-Style
Sartopore® 2 XLG 0.8 | 0.2µm Gamma MidiCaps® & MaxiCaps® T-Style
Sartopore® 2 XLM 0.2 | 0.1µm Gamma MidiCaps® & MaxiCaps® T-Style
Sartoguard® NF MidiCaps® & MaxiCaps® T-Style
Air venting Midisart® BV at inlet & outlet
Sampling
Needleless sampling site
Manifolded (2 or 4) sampling Flexboy® Bags (50 mL, 150 mL, 500 mL)
Sterilization
by Gamma Irradiation
Fluid Management Systems
3
Technical Data
Flexboy® Bags
Generic Description
InletSampling
Distribution
Outlet
Inlet
Connector
or Filter
Outlet
Connector
Flexboy®
Air venting
Flush
Bag
Waste
Bag
Flexboy®
Flexboy®
Air venting
Flexboy®
Flexboy®
Storage bag
Specifications
Shelf life: 3 years with standard components
Functionalities
– Distribution application
The validation and the use of Flexboy® bags outside of our unit
operation, application and process parameter specification ranges
are under the sole responsibility of end user. Upon request,
Sartorius Stedim Biotech Application Specialists can perform
training for optimal use of our Flexboy® products.
– Pooling application
– Storage application
– Sampling application
Application Specification
Flexboy® Bioprocessing Bag assemblies are designed for the
single-use preparation, storage, formulation and final filling
of liquid biopharmaceutical solutions, intermediates and final
bulk drug products.
Configurable manifold of Flexboy® are not designed for use in
FlexAct® MF system.
Flexboy® Bioprocessing Bags have not been qualified for freeze
and thaw applications. Freeze and thaw applications are best
covered by the Celsius® range of products that is designed and
qualified for this purpose.
Flexboy® Bioprocessing Bags have not been qualified for mixing
applications.
Flexboy® Bioprocessing Bags have not been qualified for use in
shipping applications. The validation of specific shipping systems
associated to our Flexboy® bags is under the responsibility of the
end user.
Design Specifications
Volume
Flexboy® Bags: 50 mL, 150 mL, 250 mL, 500 mL, 1,000 mL, 2 L, 3 L, 5 L, 10 L, 20 L, 50 L
50 mL, 150 mL, 500 mL
Sampling Flexboy® Bags: Manifolds of Flexboy® 3D Bags
Bag Chamber
Main line tubing
Inlet or Outlet connectors
Filters at Inlet
Sampling
Volumes & Manifolded bag
numbers
Tubing diameters on
Flexboy® bags
Tubing material on Flexboy® bags
Tubing lengths
Multiple layer film, including EVOH gas barrier layer & EVAM® contact layer
– P1 is the filling line, connected to the main line of the manifold
– P2 is the draining line
– P3 is the sampling line
Silicone TuFlux® or Si(Pt)
TPE compatible with Biowelder® and Biosealer®
Quick couplers
Triclamp and Mini Triclamp
Steam thru valves for SIP connections
Sterile-to-sterile connectors, including Opta®
Sartopore® 2 0.2µm Gamma MidiCaps® sizes 4,7, 8, 9, 0, MaxiCaps® T-Style sizes 1, 2, 3
Sartopore® Platinum 0.2µm Gamma MidiCaps® sizes 4,7, 8, 9, 0, MaxiCaps® T-Style sizes 1, 2, 3
Sartopore® 2 XLG 0.8 | 0.2µm Gamma MidiCaps® sizes 7, 8, 9, 0, MaxiCaps® T-Style sizes 1, 2, 3
Sartopore® 2 XLM 0.2 | 0.1µm Gamma MidiCaps® sizes 7, 8, 9, 0, MaxiCaps® T-Style sizes 1, 2, 3
Sartoguard® NF MidiCaps® sizes 8, 9, 0, MaxiCaps® T-Style sizes 1, 2, 3
with optional flush bag
Needleless sampling site
Manifolded sampling bags (from 50 mL to 500 mL)
2, 3, 4, 5, 6, 8 and 10 bags for 50 mL, 150 mL, 250 mL, 500 mL, 1,000 mL, 2 L, 3 L, 5 L, 10 L, 20 L
2, 3, 4 and 5 bags for 50 L
– 3 /16” + 4” (4.7 mm + 6.4 mm) for P3
– 4” + 5/16” (6.4 mm + 7.9 mm) for P1 and P2 from 50 mL to 3 L Flexboy® bags
–a
” + 15/32” (9.5 mm + 15.8 mm) for P1 and P2 from 5 L to 50 L Flexboy® bags
EVAM®
100 mm (4”) on P1 and P2
50 mm (2”) on P3
Fluid Management Systems
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Design Specifications
Main line configurations
InletSampling
Distribution
Outlet
Inlet
Connector
or Filter
Outlet
Connector
Flexboy®
Air venting
Flush
Bag
Waste
Bag
Flexboy®
Flexboy®
Flexboy®
Area
Function
Connection
Filtration
Flush bag
Air venting
Waste bag
Flexboy® Bags
Flexboy® for sampling
Not Used
Air venting
Flexboy®
Storage bag
Inlet
Fill
Sampling
Sampling
Distribution
Fill | Disconnect
●
Outlet
Transfer
●
●
●
●
●
●
●
●
●
●
Type of main line configurations:
1. Inlet
Generic description
InletSampling
Distribution
Outlet
Inlet
Connector
or Filter
Outlet
Connector
Flexboy®
Air venting
Flush
Bag
Waste
Bag
Flexboy®
Flexboy®
Flexboy®
Flexboy®
Storage bag
Functionalities
– F illing through an aseptic or non aseptic connection
– F illing through a sterilizing grade filter (0.2 μm pore size)
–O
ptional filter flush bag (5 L, 10 L)
–O
ptional Air venting filter
– F ilter disconnection with TPE tube sealing
–V
ariable tubing length for connection
to the filling point
Specifications
Flow rate
Maximum flow rate with peristaltic pumping 100 to 420 L/hr.
Flow rate varies with discharge pressure, suction, tubing size,
viscosity and product filterability.
Filter type
Sartopore® 2
0.2 µm Gamma
Sartopore® Platinum
0.2 µm Gamma
Sartopore® 2 XLG
0.8 | 0.2 µm Gamma
Sartopore® 2 XLM
0.2 | 0.1 µm Gamma
Sartoguard® NF
Air venting
Size of filter
MidiCaps® sizes 4, 7, 8, 9, 0
MaxiCaps® T-Style sizes 1, 2, 3
MidiCaps® sizes 4, 7, 8, 9, 0
MaxiCaps® T-Style sizes 1, 2, 3
MidiCaps® sizes 7, 8, 9, 0
MaxiCaps® T-Style sizes 1, 2, 3
MidiCaps® sizes 7, 8, 9, 0
MaxiCaps® T-Style sizes 1, 2, 3
MidiCaps® sizes 8, 9, 0
MaxiCaps® T-Style sizes 1, 2, 3
With optional flush bags: 5 L, 10 L & 20 L
Connectors possibilities
– T riclamp (1- 1” or 3” flange) with a triclamp cap,
gasket and union
–Q
uick coupler with plug – MPC male or female
– Plug
– Aseptiquick® Genderless HT
– Opta® SFT – aseptic connection (male or female)
– STC – CPC Steam Thru® connection (1-1” + 3” triclamp flange
or 3” + 3” triclamp flange) only for a” ID
– STC II – CPC Steam Thru® connection (1-1” + 3” triclamp
flange or 3” + 3” triclamp flange) only for a” ID
–K
PC HT – Kleenpak™ sterile connector – male or female
– Lynx® Valve ST 1” – Lynx® ST connector
(Disclaimer: Please refer to the third party user manual
and validation documentation)
Air venting option
Midisart® BV 150 mm2
Flush bag option
Volume of the bag: 5 or 10 L
Tubing diameter
ID + OD = 4” + 7/16” (6.4 mm + 11.11 mm) for 50 mL up to 3 L bags
ID + OD = a” + b” (9.53 mm + 15.88 mm) for 5 L to 50 L bags.
Tubing material
– Silicone TuFlux® or Si(Pt)
– Optional TPE section for filter removal with tube sealing
(section A).
Tubing lengths
Fixed length for section A:
– 300 mm (11.8”)
Variable length for section B only:
– 300 mm (11.8")
– 500 mm (19.7”) if no other option is specified
– 1,000 mm (3.4”)
– 1,500 mm (59”)
– 2,000 mm (78.7”) only for 5 L to 50 L bags
– 3,000 mm (118”) only for 5 L to 50 L bags
Fluid Management Systems
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2. Type of sampling
Generic description
InletSampling
Distribution
Outlet
Inlet
Connector
or Filter
Outlet
Connector
Flexboy®
Air venting
Flush
Bag
Waste
Bag
Flexboy®
Flexboy®
Air venting
Flexboy®
Flexboy®
Storage bag
Functionalities
– On line sampling
– Sample disconnections: tube to tube welding, tube sealing,
Quick Coupler
Sampling bags
– 2 or 4 + 50 ml Flexboy®
– 2 or 4 + 150 ml Flexboy®
– 2 or 4 + 500 ml Flexboy®
Specifications
Tubing diameter
ID + OD = 4” + 7/16” (6.35 mm + 11.11 mm)
Silicone tubing
Flow rate
Maximum flow rate with peristaltic pumping 240 L/hr.
Flow rate vary with discharge pressure, suction and viscosity.
Tubing material
– Silicone TuFlux® or Si(Pt)
– EVA section for sealing sampling bags for Flexboy® sampling
bags
Distal connectors on sampling bags
– Needleless connector
– Quick coupler with plug – MPC male
3. Outlet
Generic description
InletSampling
Distribution
Outlet
Inlet
Connector
or Filter
Outlet
Connector
Flexboy®
Air venting
Flush
Bag
Waste
Bag
Flexboy®
Flexboy®
Air venting
Flexboy®
Flexboy®
Storage bag
Functionalities
– Transfer through an aseptic or non aseptic connection
– Optional line waste bag (5 L, 10 L, 50 L)
– Optional Air venting filter
– Variable tubing length for transfer to further process step
at section E
– Optional TPE Tubing for line disconnection at section F
Specifications
Flow rate
Maximum flow rate with peristaltic pumping 100 to 420 L/hr.
Flow rate varies with discharge pressure, suction, tubing size
and viscosity.
Connector possibilites
– Triclamp (1- 1” or 3” flange) with a triclamp cap,
gasket and union
– Quick coupler with plug – MPC male or female
– Plug
– Aseptiquick® Genderless HT
– Opta® SFT – aseptic connection (male or female)
– STC – CPC Steam Thru® connection
(1-1” + 3” triclamp flange or 3” + 3” triclamp flange)
– STC II – CPC Steam Thru® connection
(1-1” + 3” triclamp flange or 3” + 3” triclamp flange)
– KPC HT – Kleenpak™ sterile connector – male or female
– Lynx® Valve ST 1” – Lynx® ST connector
Tubing diameter
ID + OD = 4” + 7/16” (6.4 mm + 11.11 mm) for 50 mL up to 3 L bags
ID + OD = a” + b” (9.53 mm x 15.88 mm) for 5 L to 50 L bags.
Tubing material
– S ilicone TuFlux® or Si(Pt)
– Optional TPE tubing for line disconnection with tube sealing
(F section)
Tubing lengths
Fixed length for section F:
– 300 mm (11.8”)
Variable length for section E only:
– 300 mm (11.8")
– 500 mm (19.7”) if no other option is specified
– 1,000 mm (37.4”)
– 1,500 mm (59”)
– 2,000 mm (78.7”) only for 5 L to 50 L bags
– 3,000 mm (118”) only for 5 L to 50 L bags
Air venting option
Midisart® BV 150 mm2
(Disclaimer: Please refer to the third party user manual
and validation documentation)
Fluid Management Systems
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4. Type of lines on the distribution section
Generic description
InletSampling
Distribution
Outlet
Inlet
Connector
or Filter
Outlet
Connector
Flexboy®
Air venting
Flush
Bag
Waste
Bag
Flexboy®
Flexboy®
Air venting
Flexboy®
Flexboy®
Storage bag
Section C:
Tubing material
– Silicone TuFlux® or Si(Pt)
Functionality
Adaptation for Sartorius Stedim Biotech Tray® and Rack® Systems
or flexible for customer rack system.
Tubing diameter
ID + OD = 4” + 7/16” (6.4 mm + 11.11 mm) for 50 mL up to 3 L bags
ID + OD = a” + b” (9.53 mm + 15.88 mm) for 5 L to 50 L bags.
Port
Flexboy® Bag volume
Line
Function
Normal Flow Rate (4” ID)
High Flow Rate (a” ID)
50 mL, 150 mL, 250 mL,
500 mL, 1,000 mL, 2L, 3L
5 L, 10 L, 20 L & 50 L
Tubing length (section C)
– 150 mm (5.9”) for 50 mL to 500 mL bags
– 300 mm (11.8”) for 1 L to 3 L
– 300 mm (11.8”) for SSB tray® and rack® systems from 5 L to 50 L
– 500 mm (19.7”) for 5 L to 50 L
– 750 mm (29.5”) for 5 L to 50 L
P1 connected
to main line
Line 1
P2
P3
Line 2
Line 3
Fill through main line
& disconnect
Addition
Addition
●
●
●
●
Needleless Sampling
●
Not used
●
Types of lines on distribution bags
a) Line 1 configurations on distribution bags
Bag
Connected to main line
Functionalities
The distribution bags are specifically designed
in connection with the main distribution line.
This connection allows the bag filling and the
bag disconnection
– F illing via TPE tubing and disconnection by tube sealing
– F illing via Si(Pt) tubing and Clipster® disconnection
– F illing via Si(Pt) TuFlux® or SI(Pt) tubing and disconnection by
Quick Coupler
– Filling via Si(Pt) TuFlux® and Clipster disconnection
for a” ID tubing
Specifications
Flow rate
Maximum flow rate with peristaltic
pumping = 100 to 420L/hr. Flow rate varies with discharge
pressure, tubing size, suction and viscosity.
Tubing diameter
ID + OD = 4” + 7/16” (6.4 mm + 11.11 mm) for 50 mL up to 3 L bags
ID + OD = a” + b” (9.53 mm + 15.88 mm) for 5 L to 50 L bags.
Tubing material
– Silicone TuFlux® or Si(Pt)
– TPE tubing for tube sealing and welding operations
Tubing length (section D)
– 150 mm (5.9”)
– 300 mm (11.8”)
b) Other lines configurations on distribution bags: lines P2 & P3
Functionalities
The storage bags can be configured (P2 & P3) for:
– Bag drainage
– Transfer with a peristaltic pump or by gravity
– Tube to tube welding
– Tube sealing
– Aseptic connection
– Needleless sampling
– Generic connection with TriClamp or Quick Coupler
Fluid Management Systems
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Line Type “High Flow Rate” (a” ID) for P2 only
Generic description
Bag
Functionalities
– Bag drainage
– Transfer with peristaltic pump or by gravity
– Tube to tube welding
– Tube sealing
– Aseptic connection
– Generic connection with TriClamp or Quick Coupler
Specifications
Flow Rate
Maximum flow rate with a peristaltic pump = 420 L/hr.
Flow rate varies with discharge pressure, suction and viscosity.
Tubing diameter
ID + OD = a” + 1” (9.53 mm + 15.88 mm)
Tubing materials
– Silicone TuFlux® or Si(Pt) for 10 hr maximum operation
with a peristaltic pump
– TPE (thermoplastic tubing) for tube sealing and welding
operations
– Silicone TuFlux® or Si(Pt) with a TPE extension for 10 hr
maximum operation with a peristaltic pump and for tube
sealing and welding applications.
Tubing lengths
– 150 mm (5.9”) for Silicone
– 500 mm (19.7”) for Silicone and TPE
– 1,000 mm (37.4”) for Silicone
– 1,000 mm (37.4”) total with 500 mm (19.7”) Silicone + 500 mm
(19.7”) TPE for Silicone with TPE extension
– 1,500 mm (59”) total with 1,000 mm (37.4”) Silicone + 500 mm
(19.7”) TPE for Silicone with TPE extension
Distal connectors
– TriClamp (1-1” or 3” Flange) with or without a TriClamp cap,
gasket and union
– Quick Coupler with plug – MPC
(Male or Female or Female | Female)
– Plug
– Opta® SFT – aseptic connection (Male or Female)
– Aseptiquick® Genderless HT
– STC & STCII – CPC Steam Thru® connection – with 1-1” and
3” TriClamp flange or with 3” + 3” TriClamp flange
– STC II – CPC Steam ThruR connection – with 1-½” and
¾” TriClamp flange or with ¾” + ¾” TriClamp flange
– KPC HT – Male or Female – Kleenpak™ Sterile connectors
– Lynx® Valve ST 1” – Lynx® ST connector
(Disclaimer: Please refer to the third party
user manual and validation documentation)
Line Type “Normal Flow Rate” (4” ID) for P2 and | or P3
Generic description
Bag
Functionalities
– S olution addition
– T ransfer with peristaltic pump or by gravity
– T ube to tube welding
– T ube sealing
–G
eneric connection with TriClamp or Quick Coupler
Specifications
Flow Rate
Maximum flow rate with a peristaltic pump = 240 L/hr.
Flow rate varies with discharge pressure, suction and viscosity.
Tubing diameter
ID + OD = 4” + 7/16” (6.35 mm + 11.11 mm)
Distal connectors
– TriClamp (1-1” or 3” Flange) with or without a TriClamp cap,
gasket and union
– Quick Coupler with plug – MPC
(Male or Female or Female | Female)
– Plug
– Aseptiquick® Genderless HT
– Opta® SFT – aseptic connection (Male or Female)
– Luer Lock (Male or Female)
– KPC HT – Male or Female – Kleenpak™ Sterile connectors
– Lynx® Valve ST 1” – Lynx® ST connector
(Disclaimer: Please refer to the third party
user manual and validation documentation)
Tubing materials
– Silicone TuFlux® or Si(Pt) for 10 hr
maximum operation with a peristaltic pump
– TPE (thermoplastic tubing) for tube sealing and welding
operations
Tubing lengths
– 150 mm (5.9”) for Silicone
– 500 mm (19.7”) for Silicone and TPE
– 1,000 mm (37.4”) for Silicone
– 1,000 mm (37.4”) total with 500 mm (19.7”) Silicone + 500 mm
(19.7”) TPE for Silicone with TPE extension
– 1,500 mm (59”) total with 1,000 mm (37.4”) Silicone + 500 mm
(19.7”) TPE for Silicone with TPE extension
Fluid Management Systems
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Line Type “Small Flow Rate” (8” ID) for P2 and | or P3
Generic description
Bag
Functionalities
– Solution addition
– Transfer with peristaltic pump or by gravity
– Tube to tube welding
– Tube sealing
– Generic connection with Luer Lock or Plug
Specifications
Flow Rate
Maximum flow rate with a peristaltic pump = 100 L/hr.
Flow rate varies with discharge pressure, suction and viscosity.
Tubing diameter
ID + OD = 8” + 4” (3.2 mm + 6.4 mm)
Tubing materials
– Silicone TuFlux® or Si(Pt) for 10 hr maximum operation
with a peristaltic pump
– TPE (thermoplastic tubing) for tube sealing and welding
operations
Tubing lengths
– 500 mm (19.7”) for Silicone or TPE tubing
– 1,000 mm (59”) total line length: 500 mm (19.7”) Silicone
+ 500 mm (19.7”) TPE
– 1,500 mm (59”) total line length: 1,000 mm (37.4”) Silicone
+ 500 mm (19.7”) TPE
Distal connectors
– Luer Lock (Male or Female)
– Plug (TPE only)
Line Type “Sampling” for P3 only
Generic description
Functionalities
Sampling via:
– Luer needleless sampling port or Clave connector
– Septum
Specifications
Tubing diameter
ID + OD = 4” + 7/16” (6.35 mm + 11.11 mm)
Tubing materials
– Silicone TuFlux® or Si(Pt) for needleless sampling port
and septum
– TPE (thermoplastic tubing) for tube sealing and welding
operations
Tubing lengths
– 150 mm (5.9”) for Silicone or TPE
Distal connectors
– Luer needleless sampling port or Clave connector
– Septum
Summary: Configurable Manifold of Flexboy® Bioprocessing Bags: 50 mL to 3 L
InletSampling
Distribution
Outlet
Inlet
Connector
or Filter
Outlet
Connector
Flexboy®
Air venting
Flush
Bag
Waste
Bag
Flexboy®
Flexboy®
Air venting
Flexboy®
Flexboy®
Storage bag
Main Line for Manifold of Flexboy® Bioprocessing Bags: 50 mL to 3 L (4” ID)
Inlet
Sampling
Connection
to main line
Tubing length
between distribution
bags
Outlet
Function
Fill
Filter
Sample with bags
Connect to Main line
& Disconnect
Bag distance
Options
Transfer to further
process step
Port
NA
NA
P1
NA
NA
Standard connectors
TC 1-1” + cap
TC 3” +cap
MPC – M | F
Plug
MPC – M | F
MPC – M | F
Aseptic connectors
Opta® SFT – M | F
Aseptiquick®
Opta® SFT – M | F
Aseptiquick®
Other connectors
KPC HT – M | F
Lynx® ST
KPC HT – M | F
Lynx® ST
Tube diameter
¼” + 7/16”
4” + 7/16”
¼” + 7/16”
¼” + 7/16”
¼” + 7/16”
Tube length (mm)
300 (11.8”) section A
Options at section B:
300 (11.8")
500 (19.7”)
1,000 (39.4”)
1,500 (59”)
150 (5.9”)
300 (11.8”)
Section D
150 (5.9”)
300 (11.8”)
Section C
150 (5.9”) 50 mL to
500 mL
300 (11.8”) 1 L to 3 L
300 (11.8”) section F
Options at section E
300 (11.8")
500 (19.7”)
1,000 (39.4”)
1,500 (59”)
Tubing materials
Si (Pt) TuFlux®
Si (Pt)
TPE (section A)
Si (Pt) TuFlux® + EVA
Si (Pt) + EVA
Si TuFlux® with MPC
Si (Pt) with Clipster®
Si (Pt) with MPC
TPE
Si (Pt) TuFlux®
Si (Pt)
Si (Pt) TuFlux®
Si (Pt)
TPE (section F)
Flush | Waste bag
Flush 5 L
Waste 5 L
Waste 10 L
Waste 50 L
Air venting filter
Midisart® BV
Midisart® BV
Sampling bags
Filters
TC 1-1” + cap
TC 3” +cap
MPC – M | F
Plug
2 or 4 + 50 mL
Flexboy®
2 or 4 + 150 mL
Flexboy®
2 or 4 + 500 mL
Flexboy®
– Sartopore® 2
MidiCaps 0.2 μm size 4
– Sartopore® Platinum
0.2 µm size 4
Fluid Management Systems
15
Summary: Configurable Manifold of Flexboy® Bioprocessing Bags: 5 L to 50 L
InletSampling
Distribution
Outlet
Inlet
Connector
or Filter
Outlet
Connector
Flexboy®
Air venting
Flush
Bag
Waste
Bag
Flexboy®
Flexboy®
Air venting
Flexboy®
Flexboy®
Storage bag
Main Line for Manifold of Flexboy® Bioprocessing Bags: 5 L to 50 L (a” ID)
Inlet
Sampling
Function
Fill
Filter
Sample with bags
Port
NA
NA
Standard connectors
TC 1-1” + cap
TC 3” +cap
MPC – M | F
Plug
MPC – M | F
Aseptic connectors
Opta® SFT – M | F
Aseptiquick®
STC 1-1”, ¾”
STC ¾”, ¾”
STC II 1-1”, ¾”
STC II ¾”, ¾”
Other connectors
KPC HT – M | F
Lynx® ST
Tube diameter
a” + b”
4” + 7/16”
Tube length (mm)
300 (11.8”) section A
Options at section B:
300 (11.8")
500 (19.7”)
1,000 (39.4”)
1,500 (59”)
2,000 (78.7”)
3,000 (118”)
150 (5.9”)
300 (11.8”)
Tubing materials
Si (Pt) TuFlux®
Si (Pt)
TPE (section A)
Si (Pt) TuFlux® + EVA
Si (Pt) + EVA
Flush | Waste bag
Flush 5 L
Flush 10 L
Air venting filter
Midisart® BV
2 or 4 + 50 mL Flexboy®
2 or 4 + 150 mL Flexboy®
2 or 4 + 500 mL Flexboy®
Sampling bags
Filters
– Sartopore® 2 0.2 µm Gamma MidiCaps® sizes 7, 8, 9, 0, MaxiCaps® T-Style sizes 1, 2, 3
– Sartopore® Platinum 0.2 µm Gamma MidiCaps® sizes 7, 8, 9, 0, MaxiCaps® T-Style sizes 1, 2, 3
– Sartopore® 2 XLG 0.8 | 0.2 µm Gamma MidiCaps® sizes 7, 8, 9, 0, MaxiCaps® T-Style sizes 1, 2, 3
– Sartopore® 2 XLM 0.2 | 0.1 µm Gamma MidiCaps® sizes 7, 8, 9, 0, MaxiCaps® T-Style sizes 1, 2, 3
– Sartoguard® NF MidiCaps® sizes 8, 9, 0, MaxiCaps® T-Style sizes 1, 2, 3
Connection to main line
Tubing length
between distribution bags
Outlet
Connect to Main line
& Disconnect
Bag distance
Options
Transfer to further
process step
P1
NA
NA
MPC – M | F
TC 1-1” + cap
TC 3” +cap
MPC – M | F
Plug
Opta® SFT – M | F
Aseptiquick®
STC 1-1”, ¾”
STC ¾”, ¾”
STC II 1-1”, ¾”
STC II ¾”, ¾”
KPC HT – M | F
Lynx® ST
a” + b”
a” + b”
a” + b”
Section D
150 (5.9”)
300 (11.8”)
Section C
300 (11.8”)
500 (19.7”)
750 (29.5”)
300 (11.8”) section F
Options at section E
300 (11.8")
500 (19.7”)
1,000 (39.4”)
1,500 (59”)
2,000 (78.7”)
3,000 (118”)
Sil TuFlux® with MPC
Si (Pt) with Clipster®
Si (Pt) with MPC
TPE
Si (Pt) TuFlux®
Si (Pt)
Si (Pt) TuFlux®
Si (Pt)
TPE (section F)
Waste 5 L
Waste 10 L
Waste 50 L
Midisart® BV
Fluid Management Systems
17
Storage bag configurations for the Configurable Manifold of Flexboy® Bioprocessing Bags: 50 mL to 50 L
Function
Normal Flow Rate
(4” + 7/16”)
High Flow Rate
(a” + b”)
Small Flow Rate
(8” + 4”)
Other
Sampling
Drain
Addition
Drain
Addition
Drain
Addition
Addition
Sampling
P3
Port
P2, P3
P2
P2, P3
P2
Tube Dim.
¼” + 7/16”
a” + b”
8” + ¼”
NA
4” + 7/16”
Tubing length
(mm)
150 (5.9”)
500 (19.7”)
1,000 (39.4”)
1,500 (59”)
150 (5.9”)
500 (19.7”)
1,000 (39.4”)
1,500 (59”)
500 (19.7”)
1,000 (39.4”)
1,500 (59”)
NA
150 (5.9”)
Tubing
materials
Si (Pt) TuFlux®
Si (Pt)
TPE 500 mm Only
Sil. + TPE
Si (Pt) TuFlux®
Si (Pt)
TPE 500 mm Only
Sil + TPE
Si (Pt) TuFlux®
Si (Pt)
TPE 500 mm Only
Sil. + TPE
NA
Si (Pt)TuFlux®
Si (Pt)
Standard
connectors
TC 1-1” w | wo cap
TC 3” w | wo cap
MPC M | F | FF
Luer Lock M | F
Plug
Aseptiquick®
TC 1-1” w | wo cap
TC 3” w | wo cap
MPC M | F | FF
Plug
Luer Lock M | F
Plug
Luer Lock M | F
MPC M | F | FF
Clave
Septum
Aseptic
connectors
Opta® SFT – M | F
Opta® SFT – M | F
STC 1-1”, ¾”
STC ¾”, ¾”
STC II 1-½”, ¾”
STC II ¾”, ¾”
Other
connectors
KPC HT – M | F
Lynx® ST
KPC HT – M | F
Lynx® ST
Sales and Service Contacts
For further contacts, visit www.sartorius-stedim.com
America
Germany
Sartorius Stedim Biotech GmbH
August-Spindler-Strasse 11
37079 Goettingen
Netherlands
Sartorius Stedim Netherlands B.V.
Phone +49.551.308.0
Fax +49.551.308.3289
[email protected]
Sartorius Stedim Systems GmbH
Robert-Bosch-Strasse 5 – 7
34302 Guxhagen
Poland
Sartorius Stedim Poland Sp. z o.o.
ul. Wrzesinska 70
62-025 Kostrzyn
Phone +49.5665.407.0
Fax +49.5665.407.2200
Phone +48.61.647.38.40
Fax +48.61.879.25.04
France
Sartorius Stedim FMT S.A.S.
ZI des Paluds
Avenue de Jouques – CS 91051
13781 Aubagne Cedex
Russian Federation
LLC “Sartorius ICR”and LLC “Biohit”
Uralskaya str. 4, Lit. B
199155, Saint-Petersburg
Phone +33.442.845600
Fax +33.442.845619
Phone +31.30.60.25.080
Fax +31.30.60.25.099
Phone +7.812.327.5.327
Fax +7.812.327.5.323
USA
Sartorius Stedim North America Inc.
5 Orville Drive, Suite 200
Bohemia, NY 11716
Toll-Free +1.800.368.7178
Fax +1.631.254.4253
Argentina
Sartorius Argentina S.A.
Int. A. Ávalos 4251
B1605ECS Munro
Buenos Aires
Phone +54.11.4721.0505
Fax +54.11.4762.2333
Brazil
Sartorius do Brasil Ltda
Avenida Senador Vergueiro 2962
São Bernardo do Campo
CEP 09600-000 - SP- Brasil
Phone +55.11.4362.8900
Fax + 55.11.4362.8901
Sartorius Stedim France SAS
ZI des Paluds
Avenue de Jouques – CS 71058
13781 Aubagne Cedex
Spain
Sartorius Stedim Spain, S.A.U.
Avda. de la Industria, 32
Edificio PAYMA
28108 Alcobendas (Madrid)
Phone +33.442.845600
Fax +33.442.846545
Phone +34.902.110.935
Fax +34.91.358.96.23
Austria
Sartorius Stedim Austria GmbH
Franzosengraben 12
1030 Vienna
Switzerland
Sartorius Stedim Switzerland AG
Ringstrasse 24 a
8317 Tagelswangen
Phone +43.1.7965763.18
Fax +43.1.796576344
Phone +41.52.354.36.36
Fax +41.52.354.36.46
Belgium
Sartorius Stedim Belgium N.V.
Leuvensesteenweg, 248/B
1800 Vilvoorde
U.K.
Sartorius Stedim UK Ltd.
Longmead Business Centre
Blenheim Road, Epsom
Surrey KT19 9 QQ
Australia
Sartorius Stedim Australia Pty. Ltd.
Unit 5, 7-11 Rodeo Drive
Dandenong South Vic 3175
Phone +44.1372.737159
Fax +44.1372.726171
Phone +61.3.8762.1800
Fax +61.3.8762.1828
Ukraine
LLC “Biohit”
Post Box 440 “B”
01001 Kiev, Ukraine
China
Sartorius Stedim Biotech (Beijing) Co. Ltd.
No. 33 Yu’an Road
Airport Industrial Park Zone B
Shunyi District, Beijing 101300
Phone +32.2.756.06.80
Fax +32.2.756.06.81
Hungary
Sartorius Stedim Hungária Kft.
Kagyló u. 5
2092 Budakeszi
Phone +36.23.457.227
Fax +36.23.457.147
Italy
Sartorius Stedim Italy S.p.A.
Via dell’Antella, 76/A
50012 Antella-Bagno a Ripoli (FI)
Phone +380.44.411.4918
Fax +380.50.623.3162
Phone +39.055.63.40.41
Fax +39.055.63.40.526
Mexico
Sartorius de México S.A. de C.V.
Circuito Circunvalación Poniente
No. 149
Ciudad Satélite
53100, Estado de México
México
Phone +52.5555.62.1102
Fax +52.5555.62.2942
Asia | Pacific
Phone +86.10.80426516
Fax +86.10.80426580
Sartorius Stedim Biotech (Beijing) Co. Ltd.
Shanghai Branch Office
3rd Floor, North Wing, Tower 1
No. 4560 Jin Ke Road
Pudong District, Shanghai 201210
Phone +86.21.68782300
Fax +86.21.68782332 | 68782882
Sartorius Stedim Biotech (Beijing) Co. Ltd.
Guangzhou Representative Office
Unit K, Building 23
Huihua Commerce & Trade Building
No. 80 Xianlie Middle Road
Guangzhou 510070
Phone +86.20.37618687 | 37618651
Fax +86.20.37619051
www.sartorius-stedim.com
India
Sartorius Stedim India Pvt. Ltd.
#69/2-69/3, NH 48, Jakkasandra
Nelamangala Tq
562 123 Bangalore, India
Phone +91.80.4350.5250
Fax +91.80.4350.5253
Japan
Sartorius Stedim Japan K.K.
4th Fl., Daiwa Shinagawa North Bldg.
8-11, Kita-Shinagawa 1-chome
Shinagawa-ku, Tokyo, 140-0001 Japan
Phone +81.3.4331.4300
Fax +81.3.4331.4301
Malaysia
Sartorius Stedim Malaysia Sdn. Bhd.
Lot L3-E-3B, Enterprise 4
Technology Park Malaysia
Bukit Jalil
57000 Kuala Lumpur, Malaysia
Phone +60.3.8996.0622
Fax +60.3.8996.0755
Singapore
Sartorius Stedim Singapore Pte. Ltd.
1 Science Park Road,
The Capricorn, #05-08A,
Singapore Science Park II
Singapore 117528
Phone +65.6872.3966
Fax +65.6778.2494
South Korea
Sartorius Korea Biotech Co., Ltd.
8th Floor, Solid Space B/D,
PanGyoYeok-Ro 220, BunDang-Gu
SeongNam-Si, GyeongGi-Do, 463-400
Phone +82.31.622.5700
Fax +82.31.622.5799
Specifications subject to change without notice. Printed in the EU on paper bleached without chlorine. | W
Publication No.: S--2097-e141202 · Order No.: 85037-540-90 · Ver. 12 | 2014
Europe
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